A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children

Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study

Seizure disorder other than:

Febrile seizures under the age of two years old

Seizures secondary to alcohol withdrawal more than 3 years ago, or

A singular seizure not requiring treatment within the last 3 years

Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen

Guillain-Barre Syndrome

Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)

History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing

Administration of any other investigational research agents within 30 days before the dosing

Administration of any live attenuated vaccine within 30 days before the dosing

Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing

Be receiving anti-TB prophylaxis or therapy currently

Axillary temperature > 37.0 centigrade at the time of dosing

Psychiatric condition that precludes compliance with the protocol:

Past or present psychoses

Past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years

Disorder requiring lithium

Suicidal ideation occurring within five years prior to enrollment

Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956111